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Accuracy of the Dexcom G7 Continuous Glucose Monitoring System Following Cardiac Surgery
This is a prospective longitudinal study to study the agreement between a continuous glucose monitoring system (CGMS) versus current blood glucose monitoring. Subjects in this study will have their blood glucose measured regularly every 1-3 hours with current methods in the Cardiovascular Intensive Care Unit (CVICU), and by Point of Care (POC) fingerstick glucose using the Accucheck Inform II on the regular floors, and the CGMS reading at the same time will be captured. Subjects will have measurements taken throughout their stay in the CVICU and on the regular floors. Agreement and correlation between systems, as well as errors, will be calculated.
Conditions:
🦠 Continuous Glucose Monitoring
🗓️ Study Start (Actual) 1 August 2024
🗓️ Primary Completion (Estimated) 1 July 2025
✅ Study Completion (Estimated) 1 December 2025
👥 Enrollment (Estimated) 28
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Cleveland, Ohio, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Age 18 years old and above
    • * Planned cardiothoracic surgery
    • * Planned admission to Cleveland Clinic Main Campus building J5 or J6 or Q5 cardiovascular intensive care unit (CVICU) followed by transfer to the step down unit
    • * With or without known diabetes (as 75% of patients entering the CVICU have hyperglycemia requiring intravenous insulin infusion)
    • * If with known diagnosis of diabetes, diabetes can be type 1, type 2, or secondary (such as due to glucocorticoids or pancreatitis

    Exclusion Criteria:

    • * Allergy to the material of the continuous glucose monitoring systems (CGMS) or the adhesive to be used
    • * Skin conditions precluding the use of the CGMS
    • * Pregnancy
    • * Other conditions that the investigators deem inappropriate for the study
    • * Patients receiving mechanical circulatory assist devices
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 23 March 2024
  • First Submitted that Met QC Criteria 29 March 2024
  • First Posted 1 April 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 13 June 2024
  • Last Update Posted 14 June 2024
  • Last Verified June 2024
I'm interested ...!!